DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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For product containing Red Yeast Rice, please state:Drug Registration Guidance Document (<strong>DRGD</strong>)“This product contains naturally occurring lovastatin. Please consultyour doctor/ pharmacist before using this product.”“Do not take this product if you are already on statin products(lovastatin, atorvastatin, fluvastatin, pravastatin, simvastatin,rosuvastatin,etc).”“If you experience any allergic reactions or side effects such aslethargy, body and muscle aches, please stop using this product.”“Concurrent use of fibrates may cause severe myositis andmyoglobinuria.”2.7.3 CAUTIONARY STATEMENT FOR PRODUCTS SPECIALLY USEDIN WOMENSpecial precaution shall be given to ingredients taken during pregnancy. TheAuthority urges pregnant women to consult their medical/ traditional healthcare provider prior to taking any herbal or traditional products.Unless otherwise supported, all herbal/ traditional products label shall statethe following general cautionary statement:“Pregnancy and breastfeeding: Insufficient reliable data”However, for products containing any ingredients as listed in the followinglists, i.e. List of Prohibited Ingredients in Pregnancy and List of RestrictedIngredients in Pregnancy, the following cautionary statement shall be statedin the product label:i) Prohibited Ingredients in Pregnancy:“Contraindicated in pregnant women.”ii) Restricted Ingredients in Pregnancy:“To be used with caution in pregnancy.”The list of herbs contraindicated in pregnancy is rarely in agreement as mostherbal products are used in combination. The following list has been compiledNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 292
Drug Registration Guidance Document (<strong>DRGD</strong>)based on well documented information as an aid to the industry to complywith the labelling requirement for products used during pregnancy.Table 10: List of Prohibited Ingredients in PregnancyLatin Compendium NameCommon/ ChineseNameA Acorus Calamus CalamusRemarksAchillea MillefoliumAngelica ArchangelicaYarrowAngelicaAngelica sinensis Dong Quai When taken orallyArtemisia VulgarisArctostaphylos Uva UrsiArtemisia AbsinthiumAstragalus gummiferMugwortUva UrsiWormwoodTragacanthB Bryonia Alba White BryonyBupleurum chinense,Bupleurum falcatumBupleurumC Calendula Officinalis CalendulaCapsella Bursa-PastorisCassia MarilandicaShepherd‟s PurseSennaCaulophyllum Thalictroides Blue Cohosh When taken orallyChamaemelum nobile(Anthemis nobilis)ChenopodiumAmbrosioidesCichorium intybusRoman ChamomileEpazoteChicoryWhen taken orallyCimicifuga Racemosa Black Cohosh When taken orallyCnicus BenedictusConium maculatumConvalaria MajalisCortex CinnamomiBlessed ThistleHemlockLily of the ValleyRou GuiNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 293
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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